"We’re there to help service providers continue to be healthy, viable businesses,” says Phil Roberts, Senior Vice President, Technical Operations, Orexigen. “I’m open to the concept that a static CDMO, is really a dead CDMO,” he concludes. But for Orexigen and its supply chain, it’s been much more of a mutually assured existence. Here’s part two of the journey.
You are on your weekly project conference call with your CMO, discussing a product-filling project which is on track. The CMO’s project manager says, “Oh, I am going to go off agenda and ask for your signature by today to go forward with a machine-testing plan. If we don’t do it tomorrow, we might need to push your production run by a couple of weeks.” This is the first you have heard of it, so you are reacting on several levels.
At small pharma companies, most of the CMC (chemistry, manufacturing, and controls) knowledge base is generated by a global array of outside providers. The companies are challenged to create and manage a high-functioning knowledge base of information with little or no support staff. Let’s start with some examples of the current state.
Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.
It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of blockbuster drug from South East Asia destined for Russia. In France, the roads are closed for days due to a monster snowstorm, with your irreplaceable shipment of investigational drugs stopped somewhere en route between Paris and the clinical trial site. Will all be lost, or can informed choices made before the shipment departs ensure product safety despite unforeseen circumstances?
Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises
Hypromellose capsules were originally formulated with a secondary gelling agent. This article discusses the rationale for developing Capsugel’s Vcaps Plus capsules without a gelling agent.
This application note compares cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.
In this application note, three standard field service procedures for TruDO sensors are described: replacement of the membrane, refilling of the electrolyte solution, and cleaning/replacement of the cathode.
Good column packing is essential for any chromatographic process and plays a key role in the large-scale commercial manufacture of biopharmaceuticals. A bed packed too densely may crack, which can lead to channeling and early breakthrough. A bed packed too loosely can further compress, causing a liquid gap where mixing can occur. Either instance will lead to costly process disruptions and loss of valuable product. Proper packing eliminates such concerns and ensures a stable bed that performs according to expectations over many processing cycles.
The most effective way to stop opioid dependence is to eliminate the use of these addictive drugs after surgery altogether. This was the goal of Pacira Pharmaceuticals.
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As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.
With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.